SYMPHONY 2020-00-410Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER TISSUE SLEEVE · Class 1
All models of SYMPHONY (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034533230), received between Jan 3, 2020 and Sep 9, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility4
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007370 ↗MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007356 ↗MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THEY WERE REINSERTING A SCREW TO THE PATIENT WITH A TFNA SCREWDRIVER AND THEY COULD NOT RETRACT THE SCREWDRIVER. THE SCREWDRIVER WOULD NOT RETRACT BACK TO DISENGAGE FROM THE SCREW. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TISSUE SLEEVE FOR POLY DRIVER. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10396008 ↗MalfunctionJan 3, 2020Device-Device Incompatibility; Device-Device Incompatibility
THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9547330 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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